Computer System Validation & Jira

Computer system validation and Jira

How to use GAMP® 5 principles and Jira to expedite validation

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Practical Solutions in CSV and SDLC for GXP & MedDev

Practical Solutions in CSV and SDLC for GXP & MedDev

When does a software tool require validation?

If software tools are used for any process which affects your product or quality systems, then that process has to be validated. A key distinction is that it is not the software tool as a stand alone product which needs to be validated, but rather your actual use of the product within your specific intended use which needs to be validated.
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Planning for Validation

Planning your project and planning your validation are very closely intertwined, and when your project process is mature, then these will converge to be the same thing.
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Process mapping

Before embarking on the project, it is important to first agree on the eventual business process. This is why a process mapping exercise is critical; it provides you with the opportunity to gather input from stake holders and process participants alike, and align everyone around a common goal.
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Rina Nir

CEO, Radbee

Markus Roemer

Consultant, Comes compliance services